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临床试验/NCT03622710
NCT03622710已完成不适用

Effects of Walking Training on Different Surfaces on Walking Ability, Balance Control, Lower Limb Muscle Strength, and Falls in Ambulatory Patients With Spinal Cord Injury

Khon Kaen University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
10-meter walk test (10MWT)

研究概览

简要总结

The study compares effects of 4-week walking training program on a walking track with difference surface [WTDS] and a firm ground on functional ability of ambulatory individuals with incomplete spinal cord injury [iSCI], using within- and between-group comparisons.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age at least 18 years
  • •Having an incomplete SCI (the American Spinal Cord Injury Association (ASIA) Impairment Scale or AIS C or D) (Kirshblum et al., 2011)
  • •At a sub-acute or chronic stage of injury (post injury time: PIT > 3 months) (Wirth et al., 2008; Blackwell et al., 2001)
  • •Able to walk with or without a walking device for at least 10m (Behrman et al., 2005; Lam et al., 2008; Jackson et al., 2008)
  • •Having a body mass index (BMI) between 18.5-29.9 kg/m2 (Woo et al., 2007)

排除标准

  • •Having an SCI from a progressive disease such as multiple sclerosis or malignancy
  • •Having other medical conditions that might affect ambulatory ability, such as pain in the musculoskeletal system with an intensity of pain more than 5 out of 10 on a numeric rating pain scale (Dijkers, 2010), deformities of the spine and lower extremities (i.e. scoliosis, kyphosis, and equinovarus) and other neurological or other medical disorders (thromboembolism, autonomic dysreflexia).
  • •Severe spasticity of the lower extremities (Modified Ashworth Scale (MAS) more than 2) (Bohannon & Smith, 1987; Scivoletto et al., 2008).

研究组 & 干预措施

Different surfaces

Experimental

Subjects are trained to walk over a walking track with different surfaces (WTDS) for 5 days over 4 weeks.

干预措施: Rehabilitation therapy (Other)

overground

Active Comparator

Subjects are trained to walk overground for 5 days over 4 weeks.

干预措施: Rehabilitation therapy (Other)

结局指标

主要结局

10-meter walk test (10MWT)

时间窗: Change over 4 weeks

Subjects walk at a comfortable pace along a 10m walkway. The test records the time use over the middle 4m of the walkway in order to minimize acceleration and deceleration effects. Then the average time over the 3 trials is converted to walking speed using the formula v=distance (m) /time (s)

次要结局

  • Timed up and go test (TUGT)(Change over 4 weeks)
  • Five times sit-to-stand test (FTSST)(Change over 4 weeks)
  • 6-minute walk test (6MWT)(Change over 4 weeks)
  • Incidence of fall(Six months after completing the training program.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sugalya Amatachaya

School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University

Khon Kaen University

研究点 (1)

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